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This is a randomized controlled pilot trial to establish methodological feasibility and determine whether a web-based, continuing dental education intervention regarding opioid prescribing risk mitigation strategies - consistent with ADA guidelines - produces pre-to-post changes in knowledge, motivation, and behavioral skills pertaining to the use of risk mitigation strategies when prescribing opioids in dental practice. The current study involves completion of a self-report pre-test (dentists), randomization to complete ROPEs or attention control intervention, completion of a self-report post-test (immediately following intervention/control completion), and completion of 1-month self-report follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROPEs | Experimental |
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| Control | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Responsible Opioid Prescriber Education (ROPES) | Other | The ROPEs intervention is a self-guided, web-based continuing dental education intervention. Consistent with ADA recommendations, ROPEs consists of seven modules of active content: (1) Overview; (2) Background on the Opioid Epidemic; (3) Dental Pain Management and the Role of Opioids; (4) Universal Precautions Approach; (5) Screening, Monitoring, and PDMP use; (6) Providing Patient Education; and, (7) Case Vignettes. All key intervention content is delivered via video-based platform and includes downloadable practice aides and resources. |
| Measure | Description | Time Frame |
|---|---|---|
| Methodological Feasibility: Recruitment Rate | Number of participants enrolled and randomized out of the number of individuals expressing interest and receiving log-in credentials. | Baseline completion, approximately 2 hours |
| Methodological Feasibility: Completion Rates | Percent of Patients Completing ROPES (or control) | Baseline completion, approximately 2 hours |
| Methodological Feasibility: Follow-Up Completion Rates | Percent of baseline participants completing the one-month follow-up assessment | Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up) |
| Methodological Feasibility: Time to Complete Intervention | Time participant takes to finish engaging with ROPES intervention or control intervention | Baseline completion component, approximately 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change at 1-Month Follow-Up From Baseline in Knowledge Change Questionnaire Score | The Knowledge Change Questionnaire was developed specifically for this study and contains five items that assess dentists' knowledge regarding: (1) dentists' role in curbing prescription opioid misuse, initiation to abuse, and diversion; (2) recent released guideline recommendations for standard pain management in dental practices; and, (3) risk mitigation strategies, such as prescription opioid misuse screening and use of their state's PDMP. One point is awarded for each correct response to items on the questionnaire. The questionnaire scale ranges from 0 (no correct items, least knowledge) to 5 (all correct items, most knowledge). This outcome will assess mean differences between groups in their change (from pre-test to one-month follow-up) in knowledge regarding best practices in dental opioid prescribing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jenna McCauley | Charleston | South Carolina | 29425 | United States |
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No significant pre-assignment study events occurred.
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| ID | Title | Description |
|---|---|---|
| FG000 | ROPEs | Responsible Opioid Prescriber Education (ROPES): The ROPEs intervention is a self-guided, web-based continuing dental education intervention. Consistent with ADA recommendations, ROPEs consists of seven modules of active content: (1) Overview; (2) Background on the Opioid Epidemic; (3) Dental Pain Management and the Role of Opioids; (4) Universal Precautions Approach; (5) Screening, Monitoring, and PDMP use; (6) Providing Patient Education; and, (7) Case Vignettes. All key intervention content is delivered via video-based platform and includes downloadable practice aides and resources. |
| FG001 | Control | Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants enrolled and randomized in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | ROPEs | Responsible Opioid Prescriber Education (ROPES): The ROPEs intervention is a self-guided, web-based continuing dental education intervention. Consistent with ADA recommendations, ROPEs consists of seven modules of active content: (1) Overview; (2) Background on the Opioid Epidemic; (3) Dental Pain Management and the Role of Opioids; (4) Universal Precautions Approach; (5) Screening, Monitoring, and PDMP use; (6) Providing Patient Education; and, (7) Case Vignettes. All key intervention content is delivered via video-based platform and includes downloadable practice aides and resources. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Methodological Feasibility: Recruitment Rate | Number of participants enrolled and randomized out of the number of individuals expressing interest and receiving log-in credentials. | 76 individuals received log-in credentials for this study. | Posted | Count of Participants | Participants | Baseline completion, approximately 2 hours |
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From Enrollment (completion of first item on pre-test) through 1-month post-intervention follow-up completion
As this was deemed a minimal risk study by IRB of record, with the greatest risk to participants being loss of confidentiality. This study relied on non-systematic assessment, i.e., participant report of adverse or serious adverse events. No investigator initiated assessment of adverse events was conducted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ROPEs | Responsible Opioid Prescriber Education (ROPES): The ROPEs intervention is a self-guided, web-based continuing dental education intervention. Consistent with ADA recommendations, ROPEs consists of seven modules of active content: (1) Overview; (2) Background on the Opioid Epidemic; (3) Dental Pain Management and the Role of Opioids; (4) Universal Precautions Approach; (5) Screening, Monitoring, and PDMP use; (6) Providing Patient Education; and, (7) Case Vignettes. All key intervention content is delivered via video-based platform and includes downloadable practice aides and resources. |
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This was a pilot trial intended to demonstrate methodological feasibility. Thus, the trial was not intended to be sufficiently powered to detect significant differences between the intervention and control groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jenna L. McCauley, PhD, Assistant Professor of Psychiatry | Medical University of South Carolina | 8437923922 | mccaule@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2018 | Sep 17, 2020 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 20, 2018 | Oct 9, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2018 | Oct 9, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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| Active Comparator Control | Other | An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain. |
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| Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up) |
| Change at Post-test From Baseline in Knowledge Change Questionnaire Score | The Knowledge Change Questionnaire was developed specifically for this study and contains five items that assess dentists' knowledge regarding: (1) dentists' role in curbing prescription opioid misuse, initiation to abuse, and diversion; (2) recent released guideline recommendations for standard pain management in dental practices; and, (3) risk mitigation strategies, such as prescription opioid misuse screening and use of their state's PDMP. One point is awarded for each correct response to items on the questionnaire. The questionnaire scale ranges from 0 (no correct items, least knowledge) to 5 (all correct items, most knowledge). This outcome will assess mean differences between groups in their change (from pre-test to post-test) in knowledge regarding best practices in dental opioid prescribing. | Single time point from pre-intervention to immediately post-intervention |
| BG001 | Control | Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | Methodological Feasibility: Completion Rates | Percent of Patients Completing ROPES (or control) | All enrolled participants | Posted | Count of Participants | Participants | Baseline completion, approximately 2 hours |
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| Primary | Methodological Feasibility: Follow-Up Completion Rates | Percent of baseline participants completing the one-month follow-up assessment | All enrolled participants | Posted | Count of Participants | Participants | Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up) |
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| Primary | Methodological Feasibility: Time to Complete Intervention | Time participant takes to finish engaging with ROPES intervention or control intervention | All enrolled participants who completed the intervention. Note that 1 ROPEs participant and 1 Control participant did not start/complete the intervention, thus no data was available regarding their time to completion. | Posted | Mean | Standard Deviation | Minutes | Baseline completion component, approximately 90 minutes |
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| Secondary | Change at 1-Month Follow-Up From Baseline in Knowledge Change Questionnaire Score | The Knowledge Change Questionnaire was developed specifically for this study and contains five items that assess dentists' knowledge regarding: (1) dentists' role in curbing prescription opioid misuse, initiation to abuse, and diversion; (2) recent released guideline recommendations for standard pain management in dental practices; and, (3) risk mitigation strategies, such as prescription opioid misuse screening and use of their state's PDMP. One point is awarded for each correct response to items on the questionnaire. The questionnaire scale ranges from 0 (no correct items, least knowledge) to 5 (all correct items, most knowledge). This outcome will assess mean differences between groups in their change (from pre-test to one-month follow-up) in knowledge regarding best practices in dental opioid prescribing. | All participants completing the pre-test and the 1-month follow-up. Note that 1 ROPEs participant was lost to follow-up and 3 Control participants were lost to follow-up. | Posted | Mean | Standard Deviation | Change in score on a scale | Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up) |
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| Secondary | Change at Post-test From Baseline in Knowledge Change Questionnaire Score | The Knowledge Change Questionnaire was developed specifically for this study and contains five items that assess dentists' knowledge regarding: (1) dentists' role in curbing prescription opioid misuse, initiation to abuse, and diversion; (2) recent released guideline recommendations for standard pain management in dental practices; and, (3) risk mitigation strategies, such as prescription opioid misuse screening and use of their state's PDMP. One point is awarded for each correct response to items on the questionnaire. The questionnaire scale ranges from 0 (no correct items, least knowledge) to 5 (all correct items, most knowledge). This outcome will assess mean differences between groups in their change (from pre-test to post-test) in knowledge regarding best practices in dental opioid prescribing. | All participants completing the pre-test and the post-test. Note that 1 ROPEs participant was lost to follow-up and 2 Control participants were lost to follow-up. | Posted | Mean | Standard Deviation | change in score on a scale | Single time point from pre-intervention to immediately post-intervention |
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| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Control | Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain. | 0 | 33 | 0 | 33 | 0 | 33 |
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